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NCT Number: NCT07603024

Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock

This prospective single-center clinical trial aims to evaluate the circulatory and microcirculatory effects of Shenfu Injection in patients with septic shock. The study focuses on the vascular waterfall phenomenon, which describes the relationship between arterial and venous pressures in the microcirculation.

Eligible participants with septic shock will receive an intravenous infusion of 100 mL Shenfu Injection (manufactured by China Resources Sanjiu Pharmaceutical Co., Ltd.). Hemodynamic and oxygen metabolism parameters will be measured before and 3 hours after treatment. The main goal is to determine whether Shenfu Injection influences the vascular waterfall difference, expressed as the gap between critical closure pressure and mean systemic filling pressure.

This study will also record changes in cardiac index, systemic vascular resistance, blood lactate, venous oxygen saturation, and norepinephrine requirement. Findings will provide preliminary clinical evidence about the role of Shenfu Injection in circulatory regulation during septic shock and help design future randomized controlled studies.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)

Wuhu, Anhui, 241001, China

Location contact

qiancheng xu, PhD

CONTACT

[email protected]

About this study

his prospective single-center interventional pilot study aims to evaluate the hemodynamic and microcirculatory effects of Shenfu Injection in septic shock patients, focusing on the vascular waterfall phenomenon quantified by Critical Closure Pressure (Pcc) and Mean Systemic Filling Pressure (Pmsf).

After achieving hemodynamic optimization according to Surviving Sepsis Campaign guidelines, qualified participants will receive a single intravenous infusion of 100 mL Shenfu Injection, diluted and administered over 1 hour. Hemodynamic and oxygen metabolism parameters will be recorded at baseline (within 30 minutes before infusion) and 3 hours after infusion.

Pcc and Pmsf will be determined using the inspiratory hold maneuver method via ventilator (plateau pressures of 5, 15, 25, and 35 cm H₂O). Ventricular Output (VO) and Venous Return (VR) curves will be constructed, and linear regression will yield intercepts representing Pcc and Pmsf.

The primary analysis will compare pre- and post-infusion Pcc-Pmsf differences to determine restoration or augmentation of the vascular waterfall phenomenon. Secondary parameters such as CI, SI, MAP, CVP, ScvO₂, Pcv-aCO₂, and blood lactate will be observed to evaluate overall circulatory and metabolic response.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

nclusion Criteria Septic shock diagnosed according to Sepsis-3 criteria after adequate fluid resuscitation.

Age ≥ 18 years. Within 24 hours of ICU admission. Receiving norepinephrine ≥ 0.10 µg/kg/min to maintain mean arterial pressure ≥ 65 mmHg.

Hemodynamically stable without vasopressor dose adjustment for ≥ 30 minutes before baseline measurement.

Endotracheal intubation with controlled mechanical ventilation under continuous sedation and analgesia.

Presence of both arterial and central venous catheters with PiCCO monitoring capability.

Written informed consent obtained from the patient or legally authorized representative.

Exclusion criteria

Cardiogenic shock as primary diagnosis or cardiac index < 2.2 L/min/m² after optimization.

Severe pulmonary bullae, pneumothorax, or conditions precluding safe inspiratory hold maneuvers.

Pregnancy or lactation. Expected ICU stay < 48 hours or limitation of life-sustaining therapy. Known allergy or contraindication to Shenfu Injection or its ingredients (e.g., ginseng, aconitum).

Treatment and study plan

Shenfu Injection

Drug

All participants in the study will receive a single intravenous infusion of Shenfu Injection, a traditional Chinese medicine produced by China Resources Sanjiu Pharmaceutical Co., Ltd. The injection contains extracts of Ginseng Radix et Rhizoma and Aconiti Lateralis Radix Praeparata.

Each dose consists of 100 mL Shenfu Injection, diluted in 250 mL normal saline, and administered through continuous intravenous infusion over 1 hour after initial hemodynamic stabilization according to Surviving Sepsis Campaign guidelines.

Hemodynamic measurements will be performed before infusion (within 30 minutes) and at 3 hours after infusion. Variables include critical closure pressure (Pcc), mean systemic filling pressure (Pmsf), cardiac index, systemic vascular resistance, central venous oxygen saturation, arterial-venous CO₂ difference, and blood lactate concentration.

No other investigational drugs, placebos, or control interventions are administered in this study.

Primary outcomes

  1. Change in vascular waterfall difference (Critical Closure Pressure [Pcc] - Mean Systemic Filling Pressure [Pmsf])

    Time frame: Baseline and 3 hours after infusion

    The difference between Pcc and Pmsf (in mmHg) measured via ventilator-induced inspiratory hold method during mechanical ventilation, representing presence and magnitude of vascular waterfall phenomenon.

Secondary outcomes

  1. Change in Cardiac Index (CI)

    Time frame: Baseline and 3 hours after infusion

    Cardiac index (L/min/m²) represents cardiac output standardized by body surface area and indicates overall pump function.

    CI will be measured continuously using the PiCCO hemodynamic monitoring system through arterial thermodilution.

    Values before Shenfu Injection and 3 hours post-infusion will be compared to evaluate changes in cardiac performance.

  2. Change in Stroke Index (SI)

    Time frame: Baseline and 3 hours after infusion

    Stroke index (mL/m²) reflects the amount of blood ejected from the left ventricle per beat per body-surface area, used to assess stroke volume changes.

    Measured using the PiCCO system and calculated automatically from thermodilution data.

  3. Change in Systemic Vascular Resistance Index (RIs)

    Time frame: Baseline and 3 hours after infusion.

    Calculated as (MAP - CVP)/CI (unit: mmHg · min · m²/L).

  4. Change in Critical Closure Pressure (Pcc)

    Time frame: Baseline and 3 hours after infusion.

    Pcc (mmHg) is obtained by plotting ventricular output against mean arterial pressure during ventilator inspiratory hold maneuvers.

    It represents the pressure below which small vessels collapse and microcirculatory flow ceases.

    Analyzing Pcc before and after infusion will help assess whether Shenfu Injection modifies microvascular closing pressure.

  5. Change in Mean Systemic Filling Pressure (Pmsf)

    Time frame: Baseline and 3 hours after infusion.

    Pmsf (mmHg) is the theoretical pressure at zero venous flow reflecting venous capacitance and circulating volume.

    It will be estimated from the venous return curve during inspiratory hold. Comparing values pre- and post-infusion will show any effect of Shenfu Injection on mean systemic pressure and stressed volume.

  6. Change in Central Venous Oxygen Saturation (ScvO₂)

    Time frame: Baseline and 3 hours after infusion.

    ScvO₂ (%) measures oxygen content in central venous blood and reflects balance between oxygen delivery and consumption.

    Obtained from central venous blood gas analysis. An increase may indicate improved tissue oxygenation after treatment.

  7. Change in Arterial-Venous CO₂ Difference (Pcv-aCO₂)

    Time frame: Baseline and 3 hours after infusion.

    Pcv-aCO₂ (mmHg) is the difference between central venous and arterial partial pressures of CO₂, reflecting adequacy of cardiac output and tissue perfusion.

    Measured simultaneously from arterial and central venous samples by blood gas analyzer.

  8. Change in Blood Lactate Concentration

    Time frame: Baseline and 3 hours after infusion.

    Blood lactate (mmol/L) is a biochemical marker of anaerobic metabolism and tissue hypoxia.

    Measured from arterial blood gas. Reduction after infusion may indicate improvement in microcirculatory perfusion.

  9. Change in Norepinephrine Dosage Requirement

    Time frame: Baseline and 3 hours after infusion.

    Average norepinephrine infusion rate (µg/kg/min) required to maintain mean arterial pressure ≥ 65 mmHg will be recorded.

    Decreased dose after infusion may suggest improved vasomotor tone or systemic perfusion.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wannan Medical College

Other

Registry information

Official study title

Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective Pilot Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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